Back to resultsA Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Sunitinib malate
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Sunitinib, 2/1 schedule, Renal cell carcinoma
Eligibility Criteria
Inclusion Criteria:
- Advanced renal cell carcinoma with histology confirmation
- Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest
- ECOG performance status 0 or 1
- Appropriate vital organ functions
Exclusion Criteria:
- Prior systemic treatment of mRCC
- Patients treated with any neoadjuvant or adjuvant systemic therapy
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
- Pregnant
- Allergic history to sunitinib
Sites / Locations
- Kaohsiung Medical University Chung-HO Memorial Hospital
- Kaohsiung Veterans General Hospital
- Taichung Veterans General Hospital
- National Taiwan University Hospital
- Taipei Vterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital, Linkou
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sunitinib
Arm Description
Sunitinib malate, 12.5mg/capsule, 50mg/day
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (safety and tolerability)
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
Secondary Outcome Measures
Objective Response Rate (ORR)
to evaluate the best response rate of sunitinib 2/1 schedule
progression free survival (PFS)
to evaluate the progression-free survival of sunitinib 2/1 schedule
patient reported outcome (PRO)
to evaluate the change of quality of life with sunitinib 2/1 schedule
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02626754
Brief Title
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
Official Title
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
In most sites had difficult to recruitting subjects.
Study Start Date
August 12, 2015 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
January 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
vghtpe user
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.
Detailed Description
Sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (SOC) for advanced renal cell carcinoma (RCC). However, Asian patients in real world experienced grade III/IV adverse events much more than expected. This multi-national, phase II, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in Asian people with advanced RCC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Sunitinib, 2/1 schedule, Renal cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sunitinib
Arm Type
Experimental
Arm Description
Sunitinib malate, 12.5mg/capsule, 50mg/day
Intervention Type
Drug
Intervention Name(s)
Sunitinib malate
Other Intervention Name(s)
Sutent
Intervention Description
Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (safety and tolerability)
Description
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
to evaluate the best response rate of sunitinib 2/1 schedule
Time Frame
24 months
Title
progression free survival (PFS)
Description
to evaluate the progression-free survival of sunitinib 2/1 schedule
Time Frame
24 months
Title
patient reported outcome (PRO)
Description
to evaluate the change of quality of life with sunitinib 2/1 schedule
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
single nuclear polymorphism
Description
to explore the relationship between select SNP associated with sunitinib 2/1 schedule
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced renal cell carcinoma with histology confirmation
Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest
ECOG performance status 0 or 1
Appropriate vital organ functions
Exclusion Criteria:
Prior systemic treatment of mRCC
Patients treated with any neoadjuvant or adjuvant systemic therapy
Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
Pregnant
Allergic history to sunitinib
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Hwa Chang, M.D. Ph.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-HO Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Vterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
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